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COMFORT by Weimei Lianyungang Household Articles manufacturing, Co. LTD

Medically reviewed on May 24, 2018

Dosage form: liquid
Ingredients: HYDROGEN PEROXIDE 2.65mL in 100mL
Labeler: Weimei Lianyungang Household Articles manufacturing, Co. LTD
NDC Code: 50827-650

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Hydrogen Peroxide ( Stablized) 3%

Package Label

Hydrogen Peroxide

Purpose

First Aid Antiseptics/Oral Debriding Agent

Uses

First aid to help prevent the risk of infection in minor cuts, scrapes and burns. Aids in the removal of phlegm, mucus, or other secrections assocated with occasional sore mouth

Warnings

For External Use only

Do not use: in the eyes or apply over large areas of the body longer than a week

Ask a doctor bbefore use if you have deep or punture wounds, animal bits or serious burns

Stop use and ask a doctor if the condition persists or gets worse. Sore mouth symptoms do not improve in 7 days.

Irriation, pain or redness persists or worsens. swelling, rash, or fever develops. Keep reach out of children. If swallowed, get medical help or contact a poison control center immediately.

Keep reach out of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

first aid antiseptic:

clean affected area
apply small amount of product on affected area 1-3 times a day
may be covered with a sterile bandage
if bandage, let dry first


oral debriding agent (oral rinse):


adults and children 2 years of age and over
mix with an equal amount of water
swish around in the mouth over affected area for atleast 1 minute and spit out
use up to 4x daily after meals and at bedtime or as directed by a dentist or doctor.


children under 12 years should be supervised in the use of this product
children under 2 years of age; consult a dentist or doctor

first aid antiseptic:

clean affected area
apply small amount of product on affected area 1-3 times a day
may be covered with a sterile bandage
if bandage, let dry first


oral debriding agent (oral rinse):


adults and children 2 years of age and over
mix with an equal amount of water
swish around in the mouth over affected area for atleast 1 minute and spit out
use up to 4x daily after meals and at bedtime or as directed by a dentist or doctor.


children under 12 years should be supervised in the use of this product
children under 2 years of age; consult a dentist or doctor

Other Information

Keep tightly closed and in a dark place at a controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

Purified water

COMFORT 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50827-650
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE2.65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:50827-650-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2012
Labeler - Weimei Lianyungang Household Articles manufacturing, Co. LTD (546100731)
Registrant - Weimei Lianyungang Household Articles manufacturing, Co. LTD (546100731)
Establishment
NameAddressID/FEIOperations
Weimei Lianyungang Household Articles manufacturing, Co. LTD546100731manufacture(50827-650)

 
Weimei Lianyungang Household Articles manufacturing, Co. LTD

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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